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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OXYHEALTH CORPSOLACE PERSONAL HEALTH SYSTEMHYPERBARIC CHAMBER

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OXYHEALTH CORP SOLACE PERSONAL HEALTH SYSTEM HYPERBARIC CHAMBER   Back to Search Results
Event Date 10/04/2002
Event Type  Malfunction  
Event Description

The international congress on hyperbaric medicine (ichm) is holding their tri-annual scientific meeting. The oxyhealth corp has two portable, fabric mild hyperbaric chambers on display: the vitaeris 320 and the solace personal health system. Their exhibit is physically located immediately across the room from the rptr's display. At approx 1030 hrs, one of the oxyhealth corp sales rep was preparing the solace personal health system for a demonstration dive for one of the delegates. When the sales rep was attempting to connect the air compressor to the chamber there was a loud pop. Rptr was at their display immediately across the room from the oxyhealth exhibit talking with two other meeting delegates. After hearing the pop they looked up to see the sales rep looking around the floor for something. Rptr looked down to discover a plastic quick disconnect valve on the floor approx two feet from where they were standing. Rptr presumes that the valve was not connected properly and the popping sound heard was the valve as it disconnected after initial pressurization. Further, rptr assumes that it was propelled across the room and bounced to the floor after hitting the back drape of the display booth. Rptr does not know the amount of pressure at the time of failure. Rptr picked up the valve and gave it back to the sales rep. The sales rep simply thanked rptr for giving it back.

 
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Brand NameSOLACE PERSONAL HEALTH SYSTEM
Type of DeviceHYPERBARIC CHAMBER
Manufacturer (Section F)
OXYHEALTH CORP
*
Manufacturer (Section D)
OXYHEALTH CORP
*
Device Event Key410005
MDR Report Key420970
Event Key398134
Report NumberMW1026371
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
OTHER Device ID NumberNI
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Event Location PUBLIC VENUE
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 10/04/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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